The present invention pertains to methods of treatment of the living body and apparatus used in treatment of abnormal conditions of the human body. More specifically, the present invention pertains to urinary incontinent management apparatus implanted within the body for managing the lack of urinary restraint.
Urinary incontinence (UI) is an abnormal condition of the living human body and refers to the involuntary loss of urine in sufficient amounts to be considered a social or health problem. Types of urinary incontinence include urge, stress, overflow, and functional UI.
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), at least 13,000,000 Americans, most of them women, will experience problems with UI. It is widely asserted that 50% of nursing home residents and 28%-33% of those senior citizens not under nursing home care experience UI. The NIDDK estimated that Americans spent about $27.8 billion on UI in 1995. Urinary incontinence can lead to secondary health problems such as skin irritation, ulceration, bladder infections, sleep disturbances, reduced sexual activity, and septicemias. These secondary problems increase a patient""s disability and require additional treatment resources.
Apparatus and methods of treatment for urinary incontinence are known. Over-the-counter absorbent products, deodorants, disinfectants, and skin care products are somewhat effective at managing symptoms of UI, but do not address the underlying problem. Furthermore, managing incontinence using these products and methods can lower a patient""s motivation to seek appropriate medical help. This possibility presents risk in that incontinence may be a symptom of more dangerous health problems, such as tumors of the brain, spinal cord, bladder, or prostate. Behavioral treatments for UI require patients to learn new behaviors, but work best with motivated patients willing to spend time and effort in making changes.
Medication is generally available only for treatment of urge UI. However, side effects such as blurred vision, severe dry mouth, and constipation are prevalent.
Various surgical procedures are used to treat UI. These include surgery to remove blockages, to inject collagen, to improve bladder neck position, to support or replace the function of severely weak pelvic muscles, to enlarge the bladder, and to implant catheters and other apparatus. U.S. Pat. No. 4,401,107 to Haber et al. and U.S. Pat. No. 4,551,862 to Haber each disclose a prosthetic sphincter surgically implanted around a waste elimination passage. U.S. Pat. No. 4,711,231 to Finegold et al. for a surgically-implantable prosthesis system requires use of a reservoir, pump, and fluids to control opening and closing of a waste elimination passage.
German Patent No. DE 3636-766-A to Lang discloses a duct containing one fixed and one rotatable perforated disk. Upon rotatable alignment of the perforations in each disk, the contents of a patient""s bladder or bowels may be discharged. These procedures introduce the corresponding risks associated with surgery and subsequent apparatus malfunction.
Several single-use, non-surgical apparatus for treating UI are known. The urinary control insert is a single use, balloon-tipped cylinder typically smaller than a tampon and inserted into the urethra using an applicator. The balloon inflates within the bladder, holding the apparatus in place. The balloon must be deflated and apparatus removed to urinate. A single-use foam pad, having adhesive on one side, is known which may be applied to the urethra opening to mitigate unintentional discharge. Such single-use solutions can be expensive and require repeated attention.
In view of the above described deficiencies associated with the use of known devices and methods for managing urinary incontinence, the present invention has been developed to alleviate these drawbacks and provide further benefits to the user. These enhancements and benefits are described in greater detail hereinbelow with respect to several alternative embodiments of the present invention.
The present invention is an apparatus for managing urinary flow in a host. The apparatus, which operates similar to a properly functioning sphincter, has at least two (2) states, i.e., normally closed and actuated open states. The apparatus consists of a funnel, at least one fixing arrangement, a closure member, a motive member, and an external control member. In one embodiment, the funnel is adapted to be located inside a host""s bladder and urethra and is adapted to be removably fixed in place by the fixing arrangements. A housing separates the motive member components from the external environment such as urinary tract tissue and fluids. In an alternate embodiment, the housing also separates the closure member from the external environment. The motive member is in communication with the closure member and both are positioned with respect to the funnel for changing the state of the apparatus from normally closed to actuated open and vice versa. The motive member is in communication with and responsive to an external control member to place the closure member in a position corresponding to the apparatus state input to the external control member by an operator. In another embodiment, the funnel is constructed of material such that it may be rolled with the motive member and closure member for implanting in the host.
The beneficial effects described above apply generally to the exemplary devices and mechanisms disclosed herein of the invention. The specific structures through which these benefits are delivered will be described in detail hereinbelow.